Exhibit A
BAKER v. CAMPBELL
Agreement of Experts
January 21, 2004

DEFINITIONS:
•

Serious medical need
“Serious medical need” is defined as a valid health condition that, without timely
medical intervention, will cause (1) unnecessary pain, or (2) measurable
deterioration in function (including organ function), or (3) death, or (4) substantial
risk to the public health.

•

Formulary
The “formulary” is defined as a list of medications approved for use by
practitioners. It is developed and monitored by a Pharmacy and Therapeutics
committee, with physician representation from the ADOC’s medical care
provider’s Alabama operation. The formulary process may require step-therapy
to assure cost-effectiveness. The formulary process may require pre-authorization
for selected therapeutics because of their safety profile, injudicious use by nonspecialists or high cost. There is a clear and efficient mechanism for practitioners
to request a waiver for non-formulary medications, based on medical necessity.
The formulary and waiver process for requests for waivers of the formulary are an
integral part of the medical necessity decision-making process. Non-formulary
requests will be considered similarly to requests for off-site care.

•

Medical Necessity
The following principles are intended to assist in making medical necessity
decisions that are soundly-based and consistent:

•

The intervention must be intended to be used for a medical condition.
A health intervention is an activity undertaken for the primary purpose of
diagnosing, preventing, improving or stabilizing a disease, illness or injury.
Activities that are primarily cosmetic, custodial, or part of normal existence (e.g.,
baldness or impotence), or undertaken primarily for the convenience of the
patient, family, or practitioner are not considered serious medical needs.

•

The published evidence should demonstrate that the intervention can be
expected to produce its intended effects on health outcomes.
The published evidence used to justify a determination must be peer-reviewed,
reporting scientifically well-controlled studies. The evidence should directly
relate the intervention to improvements in health.

•

There is no other intervention that produces comparable or superior results
in a more cost-effective manner.

Exhibit A

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The intervention’s expected beneficial effects on health outcomes should
outweigh its expected harmful effects.

•

Nothing in these principles should prohibit the ADOC or PHS, at their
discretion, from covering health interventions that do not meet these criteria.

•

Medical necessity will be determined by the RMD in conjunction with the site
responsible physician.

•

Clinical Guidelines
The ADOC and its medical care provider will develop and implement
chronic disease guidelines that are reasonably-based on the most current
nationally-accepted guidelines for the management of chronic and communicable
disease, customized for corrections. The targeted conditions will be prevalent
among inmates. They will be conditions for which there is a sound scientific
basis that interventions make a difference in morbidity and mortality. Further,
these will be conditions targeted as national priorities by the Surgeon General
(Healthy People 2010) or the National Committee for Quality Assurance (HEDIS
Quality Compass). These guidelines are published and periodically updated by:
Diabetes
American Diabetes Association
Hypertension
NIH-JNC
Asthma
NIH – NAEP
HIV
U.S. DHHS
MRSA
Bureau of Prisons and/or CDC
Tuberculosis, STDs CDC NCHSTP
Viral hepatitis
U.S. DHHS
Performance expectations (e.g., monitoring timelines) and performance
measurements will be summarized and made available to practitioners. The
clinical guidelines will be reviewed and updated annually, as necessary.
ELEMENTS OF ADEQUATE CARE AND TREATMENT
FOR INMATES WITH SERIOUS MEDICAL NEEDS:

•

Access to care is not unreasonably impeded.

•

Access to effective and appropriate diagnostic testing, consultation, medication
and therapeutic interventions.

•

Adoption of nationally accepted clinical guidelines for chronic and communicable
disease. This includes at least quarterly monitoring, with a physician visit and
appropriate diagnostic evaluation, for primary prevention and early detection of
complications of illness. Patients shall be evaluated for their degree of control,
and plans should be documented to improve control, when necessary. For
patients in good control, with conditions such as hypertension or epilepsy, who

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Exhibit A
have been stable for more than six months, visits may be scheduled every six
months so long as medication continuity is maintained.
•

Continuity of care including continuity of medication on transfer, at St. Clair, and
on release.

•

Health assessment for any incoming inmate who has not had such an evaluation,
or whose documentation is not available, within the past year.

•

Use of a continuously updated formulary. Requirements for step-therapy are
acceptable when medically legitimate.

•

Timely access to formulary and non-formulary medication. The non-formulary
process should not pose any barriers to time-urgent care.

•

Timely access to outside specialty care when medically necessary. The utilization
management process should not pose any barriers to time-urgent care. No
prospective approval is required in these circumstances.
All specialty referrals are to be made by a physician. The only exceptions to this
policy for an individual mid-level practitioner can be made by the regional
medical director, in writing. Nurses involved in the utilization management
process may approve referrals for specialty care or may ask for additional
demographic or clinical information. Only physicians may issue denials or
recommendations for alternative medical care. Alternative recommendations or
denials will only be made in consideration of the individual patient’s condition.
When an alternative recommendation or denial is issued, the rationale will be
clearly specified.
The medical director, or delegate, must give prior approval for all outside referrals
not anticipated by guidelines. The medical director should consider medical
information on the individual patient. The referring physician should have the
opportunity for informal and formal review of any alternative recommendation.
The approval process should not exceed five business days for non-urgent care,
measured from the date that requested information is supplied. The consideration
process shall not be unreasonably delayed.
As part of the database, the ADOC’s medical care provider will track all requests
for outside care by date, specialty or test, and medical reason. The tracking
should include the disposition of the utilization management decision. This list
will form the basis for external review.
As part of the database, the ADOC’s medical care provider will also track the date
of the appointment, and whether the patient was seen. This information will form
the basis for studying the time lag to outside care.
All non-urgent referrals will be accomplished within 60 days, or sooner according
to medical necessity. The patient will be seen by the referring physician every
thirty days until such time as the referral has been accomplished. The purpose of
these visits is to assess whether there is any reason to intervene in the process.
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Exhibit A
The ADOC’s medical care provider will submit quarterly reports to the ADOC
and to the ADOC’s monitor, we well as to the consultant of this agreement.
These reports will include counts of visits by specialty or diagnostic test, lag time
to appointments by specialty, and turnaround time on reports to primary
physicians. Data will be tracked and trended with a twelve-month tail.
The ADOC’s medical care provider will also report quarterly on hospital
discharges by diagnosis and length of stay. Data will be tracked and trended with
a twelve-month tail and reported to the Department’s consultant.
The care recommendations of the specialist will be acknowledged in the medical
record and considered. Any deviation from or override of the specialist’s
recommendations must be affirmatively medically justified in the medical record.
Prostheses, including dental, and devices such as hearing aids, will be repaired
and/or replaced in a timely manner, consistent with the medical condition of the
patient. Turnaround time should not exceed 90 days, unless there are sound
medical reasons.
•

Access to medically trained personnel for emergency transportation to hospitals.

•

Medical information is transmitted as medically appropriate to outside medical
caregivers. Medical records are available to ADOC consultant, Plaintiffs’
counsel, and any other authorized monitor/consultant. Medical records are timely
transferred when the inmate moves from one facility to another.

•

Co-payments do not apply for care required by clinical guidelines or care
requested by physicians, such as follow-up care. Co-payments shall be waived
for control of serious communicable disease control, e.g., access to care for boils
and tuberculosis.

•

Inmates will not be charged co-payments for being informed of the results of
laboratory or diagnostic tests.

•

Sick call shall not be conducted between 11:00 PM and 6:00 AM. Any inmate
presenting to the nurse more than two consecutive times for the same symptoms,
with deterioration or no improvement, will be referred to a higher-level
practitioner. Sick call will be available to inmates from every area of the facility
at least five days per week. Nurses performing sick call will be trained in the use
of nurse screening protocols, with emphasis on the timing of appropriate referral
to a higher-level practitioner. Nurses will be trained in physical assessment to
implement these protocols. The assessment and treatment plan will be
appropriate to the complaint, including timely referral to a higher-level
practitioner, if necessary.

•

Annual screening for tuberculosis will include a review of symptoms, PPD for
non-positives, chest x-ray within 96 hours for TB skin test converters, respiratory

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Exhibit A
isolation for converters with positive symptoms, and surveillance activities to
determine whether there is intramural transmission of tuberculosis.
•

Comprehensive medication management program to minimize lag time from
prescription to first dose, to maintain continuity of medication, to eliminate gaps
in prescription renewal, and to counsel and document legitimate refusals of
medication. The prescribing practitioner should be notified of any patient who is
not taking prescribed medication, as measured by missing doses on three
consecutive days.

•

Dental care shall focus on the timely treatment of emergencies, the restoration of
restorable teeth in lieu of extraction, and on dental hygiene. Cleaning will be
based on the following protocol: diabetics, seizure patients, HIV-positive
inmates, cardiac patients, and inmates at risk for periodontal disease shall receive
a cleaning on an annual basis. All other inmates shall have the opportunity for a
cleaning at least once every 24 months.

•

Clinical staff shall all undergo a rigorous credentialing process that includes
primary verification of licensure and restrictions or sanctions, and inquiry with the
National Practitioner Data Bank.

•

Licensed staff shall not practice beyond the scope of their license.

•

Consulting physicians shall be qualified in their specialty, as defined by their
hospital privileges. Nurses must have graduated from an accredited RN or LPN
program and hold applicable licenses. All other ancillary personnel must meet
applicable state regulatory requirements and training standards. Personnel
working under a license or certification who are subject to restrictions or
conditions imposed by the licensing agency, or who have formal complaints filed
against them, must immediately report such restrictions, conditions, or complaints
to the Medical Director.

•

Medical and nursing staff must be currently certified in cardio pulmonary
resuscitation (“CPR”), according to the certification schedule defined by the Red
Cross or American Heart Association. All health care staff who sees patients
shall receive regular training to maintain competence in current methods for
diagnosing and treating medical complications associated with acute and chronic
illness, including the ability to recognize when referral to a physician or specialist
is necessary.

•

Implementation of a comprehensive quality management program with a program
description and annual work plan. Activities will include communicable disease
control, pharmacy and therapeutics, mortality review, clinical guidelines, and
adherence to standards. In addition there is regular performance measurement on
access to on-site and off-site care, availability of specialty care, continuity (during
incarceration and on release), coordination between health care practitioners,
complaints, medication management, acute care, chronic disease care and
communicable disease.

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Exhibit A
•

Focus studies should be performed where problems exist. Barriers should be
identified and interventions should be designed to reduce the barriers. Remeasurement should occur to document meaningful improvement.

•

Data on performance measurements should be tracked and trended.

•

Data shall be discussed at a quality management committee, with appropriate
analysis and plans documented in the minutes.

•

Mortality reviews shall be timely and self-critical.

•

An annual program summary and evaluation shall be published within three
months of the end the year, documenting an inventory of activities, trended
performance data, self-critical analysis, and plans for the upcoming year based on
findings of the past year.

•

Medically required special diets will be ordered when determined to be necessary
by the responsible physician.

POLICIES AND PROCEDURES TO BE DEVELOPED/REFINED BY ADOC:
The following policies and procedures are subject to approval by the contract
consultant, approval that will not be unreasonably withheld:
•

Nurse screening protocols

•

Clinical Guidelines for chronic disease and communicable disease, including viral
hepatitis

•

Quality management plan, work plan, template for evaluation, performance
measurement procedures, and mortality review

•

Medication management

•

Staff training

•

Bloodborne pathogen control plan

•

Airborne pathogen control plan

•

MRSA control plan including surveillance, diagnosis, treatment, hygiene,
environmental sanitation, and exchange and laundering of linens and clothing

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Exhibit A
STAFFING:
•

Designated medical authority (MD) for facility

•

Clear chain of command for quality oversight and utilization management

•

One FTE physician equates to 40 hours of on-site, hands-on, medical care

•

This facility must have at least 40 hours physician care on-site, and 40 hours of a
mid-level practitioner such as a nurse practitioner.

•

This facility must have sixteen hours of RN coverage in every 24-hour period;
LPN’s must be supervised.

•

Sufficient staff to perform performance measurement and other quality
management functions

•

For each additional 200 inmates over the census that existed on January 21, 2004,
staffing shall be increased as follows: 0.2 FTE physician or 0.3 FTE mid-level
practitioner.
PERFORMANCE MEASUREMENT:

Criteria for Performance Measurement1
Relevance: the measure should address features of the system or practitioner that are
relevant to the stakeholder likely to make judgments about quality of care, and that are
likely to motivate efforts toward improvement in quality. The measures should
• Represent priority clinical and financial issues
• Identify areas of care with measurable opportunities for improvement
• Represent activities for which a facility or practitioner is directly accountable and
might be modifiable
• Define a scale with magnitude and direction that is unambiguous in its relation to
quality
• Motivate improvements in quality, efficiency and cost-effectiveness
Validity: Validity of a measure is influenced by measurement errors and biases, which if
unresolved, make the reliability and interpretation of the measure questionable. To be
valid, a measure should:
• Have a high level of consensus regarding its meaning and importance
• Produce comparable results when measured by different auditors (reliability)
• Produce comparable results when measured in different settings, different time
periods, or with different data sources
• Measure directly the process or outcome it is intended to measure
• Be able to be adjusted for other population characteristics which might affect the
measure but which are not necessarily under the control of the facility
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Criteria adapted from “Criteria for Measure Selection, National Committee for Quality
Assurance

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Exhibit A

Feasibility: The measure should be amenable to collection, computation, and
implementation in a way that complements existing health system approaches to
performance measurement. The measure should be:
• Clearly specified
• Inexpensive to produce
• Adhere to accepted conventions of confidentiality
• Available in a timely manner
• Amenable to audit
• Resistant to gaming
Frequency of Measurement
Each measure is to be performed every three months, unless otherwise indicated.
When performance on any individual measure equals or exceeds 90% in two successive
quarters, that individual measure can be performed every six months. When performance
falls below 90% on any individual measure, the measurement periods defaults to every
three months.
Performance measures marked with asterisks necessitate clinical judgment during
the audit. Appropriate disciplines are noted on the tool.
Nursing Sick Call
1. Seen within 36 hours of request, or 72 hours on weekends
2. Assessment appropriate to chief complaint*
3. Relevant vital signs charted*
4. Treatment plan appropriate* (e.g., refer to higher level practitioner on third
visit for same symptoms)
Urgent Care
1. Care timely*
2. Appropriate vital signs documented*
3. Appropriate MD/PA/NP assessment and plan*
Clinical Guidelines – annual review
1. The clinical guidelines and related disease management program will be based
on nationally-accepted guidelines for asthma, diabetes, HIV, epilepsy,
hyperlipidemia, viral hepatitis and hypertension, as defined above
2. For communicable disease, the guidelines conform to CDC, ACET, ACIP,
BOP etc. for STDs, TB, prevention of viral hepatitis and HIV, MRSA, etc.
Chronic Disease—PPD Positive
1. Clinical evaluation and treatment decision within 14 days*

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Exhibit A
Chronic Disease—Viral Hepatitis
1. All screening, diagnostic procedures, and treatment will occur consistent with
the medical care provider’s clinical guideline as referenced in ¶ 11 of the
Settlement Agreement.
Chronic Disease—Asthma—(Applies only to Moderate and Severe Asthma)
1. Peak flow on intake or within past 3 months
2. On inhaled steroid, as medically necessary, if the patient is classified as
moderate persistent or worse for more than four weeks.
3. Followed chronic disease guideline; assessment includes degree of control;
strategy to improve outcome if control is fair or poor or status worsened*
Chronic Disease—Diabetes [to comport with Diabetes Settlement Agreement]
1. Blood sugar on intake
2. Hemoglobin A1C performed quarterly (unless stable <7.0, then every 6
months)
3. Level 
 7.0 or documented clinical strategy within 45 days of intake (or
arrival at facility) or within past 3 months. Patients with high levels may have
interim objectives of levels greater than 7.0.
4. Dilated retinal exam within the past 12 months
5. Lipid evaluation within the past 12 months
6. Foot exam within the past 3 months
7. Urine microalbumin within the past 12 months unless one prior positive has
been documented then it is no longer needed to test.
8. Blood pressure controlled or documented attempt (threshold 130/80)
9. Low-dose enteric coated aspirin prescribed
10. Followed chronic disease guideline; assessment includes degree of control;
strategy to improve outcome if control is fair or poor or status worsened *
Chronic Disease—HIV
1. CD4 count and viral load within 45 days of intake or arrival at facility, or
within past 3 months
2. PCP prophylaxis offered within 2 weeks if CD4+ count 
 200
3. HAART therapy consideration with documentation in the medical record,
within 2 weeks if CD4+ count 
 350 or the viral load is >55,000 (RT-PCR
assay) or >30,000 (bDNA assay)
4. Followed chronic disease guideline; assessment includes degree of control;
strategy to improve outcome if control is fair or poor or status worsened *
5. Pneumovax once
6. Influenza vaccine annually, October - February
Chronic Disease—Hypertension
1. Blood pressure reading noted at intake
2. Intake blood pressure > 140 systolic or > 90 diastolic: treatment or plan will
be initiated within 14 days of identification. The diagnosis of hypertension
cannot be made with a single blood pressure reading.

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Exhibit A
3. Followed chronic disease guideline; assessment includes degree of control;
strategy to improve outcome if control is fair or poor or status worsened *
Specialty Care Access (Cardiology, Dermatology, Eye, Gynecology, Neurology,
Ophthalmology, Orthopedics, Podiatry, Pulmonary, etc.)
1. Progress note reflects need for consultation
2. Consultation ordered by a physician, physician assistant or nurse practitioner
3. Consultation accomplished within 60 days of order
4. Primary care visits every 30 days until visit is accomplished
5. Documentation of follow-up as medically appropriate.
X-Ray (chest)
1. Timely reporting of results, clinician acknowledgment and appropriate followup of abnormal chest x-rays within 72 hours after x-ray is performed*
X-Ray (non-chest)
1. Timely reporting of results, clinician acknowledgment and appropriate followup of abnormal x-ray within 96 hours after x-ray is performed*
Laboratory
1. Report back within 72 hours as appropriate
2. Clinical acknowledgment and appropriate clinical response*
Medication Administration Records
1. % of blank spaces in the five medication administration books
2. Assess % of refusals (3 consecutive days) in medication administration books
3. Assess % of refusals (3 consecutive days) with appropriate follow-up
Lag Time from Prescription to Delivery of First Dose of Medication
1. Median number of days from prescription to delivery of first dose
2. Examination of cases in longest tenth percentile for barriers
Dental Care
1. Emergency evaluations seen by a licensed, independent health care
practitioner within 24 hours
2. “Priority” patients seen within seven days, timely treatment including
restoration when appropriate
3. Ratio of restorations to extractions for the trailing three months
4. Dental hygiene visit, including cleaning, within 24 months for inmates in
custody for > 24 months
5. Documentation of providing oral health information to patients seen
6. Clear and complete documentation of visits and procedures including medical
history

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Exhibit A
Credentialing – Every 12 months
1. Assess 100% of MD/PA/NP files with validation of current license and DEA
certificate
2. Assess 100% of nursing files with validation of current license
3. Assess 100% of dental files with validation of current license
4. Assess 100% of mental health files with validation of current license
Complaints and grievances (requires a system to track and trend complaints and
grievances from inmates through all conduits)
1. Analyze trends in terms of numbers and category distribution
2. Assess % appropriately addressed within 14 days
3. Assess % answered responsive to specific complaint
Utilization Management and Alternative Treatment Plans
1. Timely
2. Medical information considered
3. Requesting practitioner informed with specified reason for the denial or
alternative treatment plan
4. Specific alternative treatment plans proposed, where applicable
Pending Off-site Referrals
1. % waiting more than 30, 60, and 90 days
2. 30 day review by primary physician, where applicable
Comprehensive quality management program
1. Quality Management Program Description and Annual work plan
2. Activities include communicable disease control, pharmacy and therapeutics,
mortality review, clinical guidelines, and adherence to standards. In addition
there is regular performance measurement on access, availability, continuity,
coordination, complaints, acute care, chronic disease care and communicable
disease. Focus studies should be performed where problems exist. Barriers
should be identified and interventions should be designed to reduce the
barriers. Re-measurement should occur to document meaningful
improvement.
3. Focused studies on all identified opportunities for improvement
4. Tracked and trended data on performance measurements
5. Minutes
6. Mortality reviews timely and self-critical
7. Annual program summary and evaluation

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